Casual Contact With Exposed Metal - Infusion Pump - Type CF Medical Device

C

cdewitt

#1
Our infusion pump is classed as a Type CF device because the needle, the applied part goes through the skin and is in direct contact with body fluids. In 60601 edition 3 par 4.6 we are to make an assessment as to whether exposed metal in the case is an applied part. If the patient makes casual contact with this exposed metal it is against his skin and not in direct contact with body fluids so the same low impedance path of the applied part, the needle does not exist.

Should this contact with exposed metal need to have the same 10uA leakage requirement as the needle or is the 100uA touch current limit in 8.7.3 c sufficient?
 
Elsmar Forum Sponsor
#3
If you were to consider the outer case as being a part that can contact the patient and needs to be considered as an applied part then a classification of type B would be OK. As such the the touch currents are the 100/500uA as given in 8.7.3c with some further consideration given in Table 3.
 
C

cdewitt

#4
Since this is an infusion pump Type B is not possible. 60601-2-24 says infuion pumps are either type BF or type CF. Because this is a device used with direct connection to the blood system the CF rating is appropriote for the IV tube and not an issue but I'm not sure that just skin touch of the case is the same thing.
 
#5
The standard will say that the Applied Part must be BF or CF.

The case is not the Applied Part, but may need to offer the same protection as if it was one. For that I would suggest type B.
 

Peter Selvey

Staff member
Super Moderator
#6
If I understand correctly, we are talking about the case of the pump itself. It would be a stretch to treat this as Type BF or CF, and would be impractical from a design point of view.

Keep in mind any decision based on risk requires the judgment to be made on the probability of harm, not the probability of a single event in the full sequence. The standard implies the judgement is to be made on the probability of contact, but this dead wrong, that is just one event in series of events, which include some other pretty improbable events. Think about it ... if the patient contacting the case was a real risk, then everyone, operator, nurse, friends could all be at risk ...

Already the basic classification of CF for an infusion pump is a bit of a fudge because it relies on the insulation in the tubing, which is outside of the manufacturer's control. I am fairly confident that NRTLs do not enforce 1.5kV production tests on the infusion sets :)
 
C

cdewitt

#7
I've got one source telling me that since it's an infusion pump and needs to meet 60601-2-24 which says all applied parts need to be BF or CF, if we decide the case is an "applied part" from edition 3 par 4.6 it (the case) can't be Type B. It dosn't exist on an infusion pump.
 
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